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Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses

Primary Purpose

Patellofemoral Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Foot orthoses
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Patellofemoral Pain Syndrome focused on measuring Patellofemoral pain syndrome, Feet orthoses, KOOS

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged 12-40 years
  • Patellofemoral pain syndrome
  • Patient affiliated to a social protection regime
  • Patient who signed an informed consent
  • For teenagers with no complete growth and muscular maturation, failure of appropriate rehabilitation during minimum 2 months
  • Patient informed of the results of the prior medical examination
  • Normality (no sign of osteoarthritis) of the knee radiographs
  • Ability to read and understand French

Exclusion Criteria:

  • Knee osteoarthritis
  • Systemic disease
  • Inflammatory rheumatism disease
  • Unstable knee
  • Prior patellofemoral dislocation
  • Osteochondrosis
  • Referred pain from a hip or spine disease (particularly proximal femoral epiphysiolysis in the teenagers)
  • A history of patellar trauma
  • A history of knee surgery
  • Meniscus, ligament or osteochondral pathology
  • Knee tendinitis or bursitis
  • Neurologic disease
  • Pregnancy
  • Antidepressant therapy or behavioral disorder
  • Patient unable to comply the required maximum observance
  • Impossibility to give enlightened information to the patient
  • Patient under guardianship

Sites / Locations

  • Cabinet libéral - 12, rue du PuitsRecruiting
  • Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de StrasbourgRecruiting
  • Cabinet libéral - 50, avenue des VosgesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Morpho-specific foot orthoses

Placebo foot orthoses

Arm Description

Morpho-specific thermo-molded foot orthoses are designed according to the patient's morphotype. Orthoses are custom-molded from different materials such as BIOFLUX resin, Covercuir MF, EVA300/60, EVA400/70, PE255/55, ABSORB Dur and CAPITON PU.

The placebo foot orthoses will be made with the same principle of molding and with the same materials as for the experimental group. The only difference is that they involve no active corrective insert element : they will be made without morphotype correction.

Outcomes

Primary Outcome Measures

Item Pain of the KOOS Score

Secondary Outcome Measures

KOOS Score (items Symptoms, Activities of daily living, Sport and recreation function, Knee-related quality of life)
Kujala Score
Pain level
Visual Analog Scale (VAS)

Full Information

First Posted
September 16, 2014
Last Updated
August 6, 2015
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02250144
Brief Title
Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses
Official Title
Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload. A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the outcome of morpho-specific foot orthoses in a prospective randomized study. The purpose of this prospective randomized study is to compare clinical outcomes in daily living and in sports activities, between morpho-specific and placebo foot orthoses. Morpho-specific foot orthoses are designed according to the patient's morphotype. They are intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to correct abnormal overload during patellofemoral tracking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Patellofemoral pain syndrome, Feet orthoses, KOOS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morpho-specific foot orthoses
Arm Type
Experimental
Arm Description
Morpho-specific thermo-molded foot orthoses are designed according to the patient's morphotype. Orthoses are custom-molded from different materials such as BIOFLUX resin, Covercuir MF, EVA300/60, EVA400/70, PE255/55, ABSORB Dur and CAPITON PU.
Arm Title
Placebo foot orthoses
Arm Type
Placebo Comparator
Arm Description
The placebo foot orthoses will be made with the same principle of molding and with the same materials as for the experimental group. The only difference is that they involve no active corrective insert element : they will be made without morphotype correction.
Intervention Type
Device
Intervention Name(s)
Foot orthoses
Primary Outcome Measure Information:
Title
Item Pain of the KOOS Score
Time Frame
Twice : at inclusion and at 10 weeks follow-up with feet orthoses
Secondary Outcome Measure Information:
Title
KOOS Score (items Symptoms, Activities of daily living, Sport and recreation function, Knee-related quality of life)
Time Frame
Twice : at inclusion and at 10 weeks follow-up with feet orthoses
Title
Kujala Score
Time Frame
Twice : at inclusion and at 10 weeks follow-up with feet orthoses
Title
Pain level
Description
Visual Analog Scale (VAS)
Time Frame
Twice : at inclusion and at 10 weeks follow-up with feet orthoses

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 12-40 years Patellofemoral pain syndrome Patient affiliated to a social protection regime Patient who signed an informed consent For teenagers with no complete growth and muscular maturation, failure of appropriate rehabilitation during minimum 2 months Patient informed of the results of the prior medical examination Normality (no sign of osteoarthritis) of the knee radiographs Ability to read and understand French Exclusion Criteria: Knee osteoarthritis Systemic disease Inflammatory rheumatism disease Unstable knee Prior patellofemoral dislocation Osteochondrosis Referred pain from a hip or spine disease (particularly proximal femoral epiphysiolysis in the teenagers) A history of patellar trauma A history of knee surgery Meniscus, ligament or osteochondral pathology Knee tendinitis or bursitis Neurologic disease Pregnancy Antidepressant therapy or behavioral disorder Patient unable to comply the required maximum observance Impossibility to give enlightened information to the patient Patient under guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yann DIESINGER, MD
Phone
388552310
Ext
0033
Email
yann.diesinger@chru-strasbourg.fr
Facility Information:
Facility Name
Cabinet libéral - 12, rue du Puits
City
Haguenau
ZIP/Postal Code
67500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph ARNDT, MD
Email
joseph.arndt@hotmail.fr
First Name & Middle Initial & Last Name & Degree
Joseph ARNDT, MD
Facility Name
Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de Strasbourg
City
Illkirch Graffenstaden
ZIP/Postal Code
67400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann DIESINGER, MD
Phone
388552310
Ext
0033
Email
yann.diesinger@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Yann DIESINGER, MD
Facility Name
Cabinet libéral - 50, avenue des Vosges
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian LUTZ, MD
Email
lutzortho@wanadoo.fr
First Name & Middle Initial & Last Name & Degree
Christian LUTZ, MD

12. IPD Sharing Statement

Learn more about this trial

Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses

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